The U.S. Food and Drug Administration has raised concerns about a potential risk of heart infection from Novavax Inc’s NVAX.OCOVID-19 vaccine, even as the company’s data showed it could reduce the chances of developing mild to severe illness.
In the Novavax trial of nearly 30,000 patients, conducted between December 2020 and September 2021, there were four cases of a type of heart inflammation called myocarditis detected within 20 days of taking the protein-based shot.
“These events raise concern that there may be a causal relationship with this vaccine, similar to the documented association with COVID-19 mRNA vaccines,” Food and Drug Administration staff wrote in summary documents released Friday.
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The company’s shares fell nearly 14% after the Food and Drug Administration analyzed data from the company’s experience.
The agency said it had asked Novavax to report myocarditis and another type of heart inflammation called pericarditis as an “important specific risk” in its materials. The company has not yet agreed to do so.
Novavax, in response to the safety concerns noted by the FDA, said that normal background events for myocarditis can be predicted in any sufficiently large database.
“Based on our interpretation of all clinical data supporting NVX-CoV2373…we believe there is insufficient evidence to establish a causal relationship,” the company said in a statement.
One patient in the trial reported myocarditis after taking a placebo.
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Novavax said the vaccine, NVX-CoV2373, will play a leading role in vaccination among those reluctant to get vaccinated, and it has begun an education effort on vaccine options.
“Despite the widespread availability of authorized or approved vaccines, the SARS-CoV-2 pandemic is not well controlled in the United States … There is still a desire for vaccines developed using well-understood technology platforms,” she said.
The US Food and Drug Administration (FDA) analyzed data from the Novavax trial before the Omicron and Delta variant became dominant strains.
“Based on the assessment of efficacy in the clinical trial of this vaccine, it is more likely than not available that the vaccine will provide a beneficial level of protection against COVID-19 due to Omicron, particularly against more serious diseases,” FDA staff said.
The vaccine showed an efficacy of 90.4% in the Novavax study, which included adults throughout the United States and Mexico.
The FDA’s comments came in a briefing note initially prepared before the May 7 meeting of the agency’s external advisors.
Its staff’s comments will be used by these advisors to guide their decision on whether or not to recommend a vaccine license on Tuesday. The FDA is not mandated to follow the advice of its outside experts, but it usually does.
(Reporting by Manas Mishra and Mrinalika Roy in Bengaluru, and Michael Erman in New Jersey; Editing by Sumiyadep Chakrabarti, David Holmes and Devika Siamnath)